WO2023170505A1 - Procédé de calcul de la forme d'une tige d'un système de vis pédiculaires pour spondylodèse - Google Patents

Procédé de calcul de la forme d'une tige d'un système de vis pédiculaires pour spondylodèse Download PDF

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Publication number
WO2023170505A1
WO2023170505A1 PCT/IB2023/051721 IB2023051721W WO2023170505A1 WO 2023170505 A1 WO2023170505 A1 WO 2023170505A1 IB 2023051721 W IB2023051721 W IB 2023051721W WO 2023170505 A1 WO2023170505 A1 WO 2023170505A1
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WO
WIPO (PCT)
Prior art keywords
tridimensional
spine
calculating
corrected
model
Prior art date
Application number
PCT/IB2023/051721
Other languages
English (en)
Inventor
Francesco Siccardi
Meinrad Fiechter
Original Assignee
Medacta International Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medacta International Sa filed Critical Medacta International Sa
Publication of WO2023170505A1 publication Critical patent/WO2023170505A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides

Definitions

  • the present invention relates to a method for calculating the shape of a rod of a pedicle screw system for spinal fusion.
  • Spinal fusion is a surgery treatment to permanently connect two or more vertebrae of a spine, thus eliminating motion between them for stabilizing a vertebral segment of a patient.
  • Rods are usually used to connect pedicle screws which are inserted into vertebral bodies, to strengthen the spine of a patient.
  • Pedicle screws are surgical instruments which allow to reinforce spinal fusion in cases of injury of the spine of a patient and they comprise a tulip and a screw.
  • Curvature abnormality of the spine scoliosis or kyphosis
  • spinal vertebrae injury protrusion of the cushioning disk between vertebrae (slipped disk, herniated nucleus pulposus) and weak or unstable spine caused by diseases are some cases in which spinal fusion is usually applied.
  • the pedicle screw is a particular type of bone screw designed for implantation into a vertebral pedicle that provides means for grasping a spinal segment at any level of a spinal column (cervical, thoracic and lumbosacral).
  • a rod is a metal cylinder implant used in spinal surgery to stabilize a vertebral segment, by connecting pedicle screws inserted into adjacent vertebral bodies in order to prevent motion and allow fusion to occur across the disc space.
  • rods are bended inside the operating room during surgery, depending on the screw position and the correction required for each patient.
  • the rod bending process requires a lot of assumption since the rod has to go into the tulip of the pedicle screws, but it is also used as point of contact in order to correct the spine.
  • a patient specific rod or a rod template could therefore provide a lot of value to the patient and to the surgeon.
  • FIG. 1 shows a block diagram of the step of a method for calculating the shape of a rod of a pedicle screw system for spinal fusion according to the present invention
  • FIG. 2 shows a system for calculating the shape of a rod of a pedicle screw system for spinal fusion according to the present invention.
  • FIG. 1 shows a block diagram of the step of a method for calculating the shape of a rod of a pedicle screw system for spinal fusion according to the present invention.
  • a first step 10 at least one bidimensional x-ray image of the spine of a patient is acquired, preferably in standing position, preferably a lateral x-ray (sagittal) image or an anterior-posterior x-ray image, the bidimensional image preferably including a pelvic region such as the sacrum and the hip joint-portion the thoracolumbar spine as well as the C7 in the cervical spine.
  • the bidimensional image includes a plurality of vertebrae.
  • a tridimensional scan image of the spine of the patient is acquired, for example a CT or a MRI image.
  • a segmentation and a tridimensional reconstruction of the vertebrae contained in such tridimensional scan image is performed, for each level, as here below disclosed.
  • tridimensional scan acquisition it is possible to acquire all the tridimensional images of the vertebrae from a predefined database or to acquire partial image of the patient from the tridimensional scan acquisition and partial image of the spine from the database, as here below detailed.
  • a tridimensional virtual complete model of the spine is obtained, in a manner per se known, starting from the scan image of the spine of step 20 and merged with the information provided from the x-ray acquisition of step 10.
  • tridimensional images of a lower extremity of the spine are added to the complete model of the spine.
  • a selection of at least one tridimensional reconstructed vertebra/sacrum/pelvic image from a predefined database of patient specific tridimensional vertebrae is performed, wherein the reconstructed image is selected based on a best fit between the tridimensional (3D) geometry of the vertebrae of the database and the contour given for each vertebra by the bidimensional x-ray image, i.e. the sagittal or anterior-posterior image of step 10, and then they are combined, at step 50, to obtain a reconstructed tridimensional model of the spine.
  • the at least one tridimensional image of the reconstructed vertebra of the database is matched, for example by using a DDR (Digital Reconstructed Radiograph) algorithm or any other algorithm using particular landmarks or geometries to do a matching of tridimensional information, to the bidimensional images of the vertebrae of the x-ray acquisition, in order to obtain the tridimensional virtual reconstructed model of the spine and the pelvic region.
  • DDR Digital Reconstructed Radiograph
  • either the x-ray image or the tridimensional model of the spine (complete or reconstructed) is used to perform a first sagittal balance analysis to calculate spino pelvic parameters such as pelvic incident, sacral slope, pelvic tilt, lumbar lordosis, thoracic kyphosis, sagittal vertical axis, and then these spino pelvic parameters are compared with predetermined range values reported in literature.
  • predetermined tridimensional simulated corrections are applied to the tridimensional model of the spine, e.g. an open or closed wedge.
  • corrected spino pelvic parameters are calculated on such tridimensional model of the spine corrected with the simulated corrections and compared with the predetermined range values reported in literature to understand if a desired balanced spine is achieved.
  • step 70 is repeated until corrected spino pelvic parameters belonging to the predetermined range values are obtained.
  • the method may proceed to the next step.
  • the bidimensional x-ray image and/or a coronal plane of the tridimensional model of the spine are elaborated to determine, in a manner per se known, the Cobb angle and the correctied parameters if necessary.
  • first predetermined additional correction factors are added to modify the corrected spino pelvic parameters, based on the surgical technique to apply as well as the expected mobility and stiffness on the spine among others, to take plastic and elastic material deformation of the rod into account.
  • second predetermined additional correction factors are applied to the corrected spino pelvic parameters to take into account pelvic and lower extremity alignment such as, for example, mechanical axis, gait and general movement analysis.
  • the corrected spino pelvic parameters as above determined correspond to acceptable spino pelvic parameters and, if necessary, to an adequate coronal plane correction (Cobb angle).
  • the corrected spino pelvic parameters have been obtained, as above disclosed, by applying the predetermined tridimensional simulated corrections to the tridimensional model of the spine, these simulated corrections corresponding, in a manner per se known, to predetermined surgical steps that have to be applied to the patient by the surgeon, for example, the insertion of cages in predetermined points of the spine, to get the balanced spine, as here below detailed.
  • a tridimensional corrected model of the spine is obtained based on said tridimensional simulated corrections.
  • Such tridimensional simulated corrections include insertion, in predetermined positions, of virtual screws and/or, advantageously, virtual cages, into the tridimensional model of the spine.
  • Screw entry points and entry directions of the virtual screws are calculated in a manner per se known.
  • Virtual screws and screw trajectories can be applied either to the right and/or to the left side of the spine in particular the pedidle, the sacrum and the Ilium.
  • the shape of the rod is calculated, based on the position of the virtual screws or the defined screw entry points, by calculating the mathematical function which best approximates the curve passing through the screw insertion points (i.e, through the virtual screws themselves or through their entry points).
  • the resulting mathematical formula represents the shape of the rod. Additional parameters for under/overcorrection of the rod can be implemented depending on e.g., an expected rigidity of the spine or a particular technique used for the correction
  • the process according to the invention is performed by a system of the type illustrated in Figure 2 comprising a workstation 200 of known type having a processing subsystem 210, a display device 220, a keyboard 230, a pointing device (mouse) 240, and a device for connecting to a local area network (network bus) 250.
  • a workstation 200 of known type having a processing subsystem 210, a display device 220, a keyboard 230, a pointing device (mouse) 240, and a device for connecting to a local area network (network bus) 250.
  • the processing system may be of a distributed type (not illustrated) having a processing subsystem and local or remote peripheral input/output devices.
  • the workstation 200 or distributed system is arranged to process processing groups or modules and computational programs that are stored on a disk or are accessible over a network and that are suitable for displaying the described process to display results on the device 220.

Abstract

Procédé de calcul de la forme d'une tige d'un système de vis pédiculaires consistant à : a) acquérir (10) au moins une image bidimensionnelle d'une colonne vertébrale ; b) acquérir (20) une image tridimensionnelle d'une colonne vertébrale ; c) obtenir (30 ; 40, 50) un modèle tridimensionnel de la colonne vertébrale ; d) effectuer (60) une analyse d'équilibre sagittal pour calculer des paramètres spino-pelviens et les comparer à des valeurs prédéterminées ; e) appliquer (70) des corrections au modèle tridimensionnel ; f) calculer (80) des paramètres spino-pelviens corrigés sur le modèle tridimensionnel de la colonne vertébrale corrigé et vérifier s'ils se situent dans les valeurs prédéterminées pour la plage, g) dans la négative, répéter les étapes e) et f) ; i) dans l'affirmative, obtenir (90) un modèle tridimensionnel corrigé de la colonne vertébrale sur la base de telles corrections tridimensionnelles simulées comprenant une pluralité de vis virtuelles ; j) calculer (100) la forme de la tige sous la forme d'une fonction mathématique qui se rapproche de la courbe passant à travers la vis virtuelle.
PCT/IB2023/051721 2022-03-08 2023-02-24 Procédé de calcul de la forme d'une tige d'un système de vis pédiculaires pour spondylodèse WO2023170505A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202200004382 2022-03-08
IT102022000004382 2022-03-08

Publications (1)

Publication Number Publication Date
WO2023170505A1 true WO2023170505A1 (fr) 2023-09-14

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PCT/IB2023/051721 WO2023170505A1 (fr) 2022-03-08 2023-02-24 Procédé de calcul de la forme d'une tige d'un système de vis pédiculaires pour spondylodèse

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160242857A1 (en) * 2015-02-13 2016-08-25 Nuvasive, Inc. Systems and methods for planning, performing, and assessing spinal correction during surgery
US20180092699A1 (en) * 2016-10-05 2018-04-05 Nuvasive, Inc. Surgical Navigation Systems and Methods
US9968408B1 (en) * 2013-03-15 2018-05-15 Nuvasive, Inc. Spinal balance assessment
WO2018131045A1 (fr) * 2017-01-12 2018-07-19 Mazor Robotics Ltd. Équilibre global utilisant une analyse de mouvement dynamique
US20180301213A1 (en) * 2015-10-13 2018-10-18 Mazor Robotics Ltd. Global spinal alignment method
US20200015857A1 (en) * 2017-11-09 2020-01-16 Globus Medical, Inc. Methods providing bend plans for surgical rods and related controllers and computer program products
WO2020201353A1 (fr) * 2019-04-02 2020-10-08 Medicrea International Systèmes, procédés et dispositifs pour développer des implants spinaux spécifiques d'un patient, des traitements, des opérations et/ou des procédures
US20200345420A1 (en) * 2017-09-01 2020-11-05 Spinologics Inc. Spinal correction rod implant manufacturing process part

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9968408B1 (en) * 2013-03-15 2018-05-15 Nuvasive, Inc. Spinal balance assessment
US20160242857A1 (en) * 2015-02-13 2016-08-25 Nuvasive, Inc. Systems and methods for planning, performing, and assessing spinal correction during surgery
US20180301213A1 (en) * 2015-10-13 2018-10-18 Mazor Robotics Ltd. Global spinal alignment method
US20180092699A1 (en) * 2016-10-05 2018-04-05 Nuvasive, Inc. Surgical Navigation Systems and Methods
WO2018131045A1 (fr) * 2017-01-12 2018-07-19 Mazor Robotics Ltd. Équilibre global utilisant une analyse de mouvement dynamique
US20200345420A1 (en) * 2017-09-01 2020-11-05 Spinologics Inc. Spinal correction rod implant manufacturing process part
US20200015857A1 (en) * 2017-11-09 2020-01-16 Globus Medical, Inc. Methods providing bend plans for surgical rods and related controllers and computer program products
WO2020201353A1 (fr) * 2019-04-02 2020-10-08 Medicrea International Systèmes, procédés et dispositifs pour développer des implants spinaux spécifiques d'un patient, des traitements, des opérations et/ou des procédures

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